A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1).

Background: V114 (15-valent pneumococcal conjugate vaccine [PCV]) contains all serotypes in 13-valent PCV (PCV13) and additional serotypes 22F and 33F. This study evaluated safety and immunogenicity of V114 compared with PCV13 in healthy infants, and concomitant administration with DTPa-HBV-IPV/Hib and rotavirus RV1 vaccines.

Methods: V114 and PCV13 were administered in a 2+1 schedule at 2, 4, and 11-15 months of age.

Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study.

Sickle cell disease (SCD) is an inherited red blood cell disease that results in a multitude of medical complications, including an increased risk of invasive disease caused by encapsulated bacteria, such as Streptococcus pneumoniae. Pneumococcal vaccines have contributed to a significant reduction in pneumococcal disease (PD) in children and adults, including those with SCD. This phase 3 study evaluated the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), in children with SCD.

Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial.

Background: We report on the safety and immunogenicity of V591, a measles vector-based SARS-CoV-2 vaccine candidate.

Methods: In this multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial, healthy adults with no history of COVID-19 disease were assigned to intramuscular injection of V591 or placebo (4:1 ratio). In part 1, younger adults (18-55 years) received V591 median tissue culture infectious dose (TCID)-levels of 1×10 or 1×10 or placebo, 56 days apart.

Safety and Immunogenicity of M-M-RII (Combination Measles-Mumps-Rubella Vaccine) in Clinical Trials of Healthy Children Conducted Between 1988 and 2009.

Background: M-M-RII, a combination measles, mumps and rubella vaccine, was licensed in the United States in 1978 based on data from several clinical trials that demonstrated that the safety and immunogenicity of the vaccine were comparable to the component monovalent vaccines and to the previous trivalent combination vaccine.

Methods: Safety and immunogenicity data from 23 postlicensure clinical trials conducted with M-M-RII between 1988 and 2009 were summarized. A total of 12,901 children who received only a first dose, 920 children who received a first and second dose and 400 children who received only a second dose were evaluated.